Kornimate/medical-research-clean huggingface dataset:
self-help cognitive behavioral therapy (cbt) for insomnia

Conditions: Insomnia

Summary: the purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffering from insomnia, also for persons presenting with different kinds of co-morbid problems.

cbt has previously been identified as an effective treatment for insomnia. however, there is a lack of trained cbt-therapists, and self-help is beginning to prove useful for many areas of psychological distress. earlier studies of different kinds of self-help (e.g. computer based and bibliotherapeutic) suggest that many patients do indeed benefit from self-help treatments for insomnia, but there is a need for independent replications. also, most previous studies have had very strict inclusion criteria, such that for instance only individuals with primary insomnia and no co-morbid problems have been included. a general question in self-help is whether patients need therapist support to benefit from treatment, or if a book is enough to alleviate symptoms.

Eligibility criteria:
inclusion criteria: * age 18 and above * diagnosis of insomnia (research diagnostic criteria) * access to computer * ability to read and write swedish exclusion criteria: * severe psychopathology (e.g. bipolar disorder, suicidality) * shift work

Keywords: insomnia co-morbid cbt self-help bibliotherapy
predictors of intracranial atherosclerotic disease in posterior circulation: a cohort study

Conditions: Stroke, Ischemic; Intracranial Atherosclerosis; Posterior Circulation Brain Infarction

Summary: early identification of intracranial atherosclerotic disease (icad) may impact the management of patients undergoing mechanical thrombectomy (mt). the aim of the study is to develop and validate a scoring system for pre-thrombectomy diagnosis of icad in posterior circulation large vessel/distal medium vessel occlusion strokes (lvos/dmvos).


Eligibility criteria:
inclusion criteria: 1. adult ≥18 years 2. patient with posterior circulation strokes who underwent mechanical thrombectomy. exclusion criteria: 1. patients with anterior circulation stroke. 2. patients with intracranial hemorrhage 3. patients without baseline radiological data. 4. extracranial large vessel atherosclerosis related strokes.
safety and effectiveness of lamivudine when given once a day versus twice a day in combination with other anti-hiv drugs in hiv-infected adults who have never received anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3tc) once a day versus twice a day as part of an anti-hiv drug combination.

patients are randomized to receive the same total dosage of 3tc either twice a day (group 1) or once a day (group 2) in combination with zdv and efv over 48 weeks. viral load measurements will be performed at weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are 18 years of age or older. * are hiv-positive. * have a viral load (level of hiv in the blood) of at least 400 copies/ml within 21 days of study entry. * have a cd4 count greater than 100 cells/mm3 within 21 days of study entry. * agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children). exclusion criteria patients will not be eligible for this study if they: * have taken any antiretroviral (anti-hiv) agent. * are pregnant or breast-feeding. * are unable to absorb food or have trouble taking medicines by mouth. * abuse alcohol or drugs to an extent that may make study participation difficult. * are not likely to be able to complete the 48 weeks of study treatment. * have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease. * have received an investigational vaccine within the past 3 months or have received gene therapy. * have a severe medical condition such as diabetes or heart trouble. * have been diagnosed with aids. * have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of kaposi's sarcoma. * are taking medications that affect the immune system within 30 days of study entry. * are taking medications that may interact with the study drugs.

Keywords: hiv-1 drug therapy, combination zidovudine drug administration schedule lamivudine genotype phenotype reverse transcriptase inhibitors anti-hiv agents viral load efavirenz
feedback system of proms in children with burns

Conditions: Burns

Summary: the primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers boq results to physicians in "real time" during outpatient encounters using ipads.

the primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment. the secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the boq+p and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). for this reason we will collect a brief debriefing questionnaire from physicians and another from parents.

Eligibility criteria:
inclusion criteria: * children between the ages of 0 and 18 years of age, receiving outpatient burn care at shriners hospitals for children - boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. english or spanish speaking and literate exclusion criteria: * clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.

Keywords: patient reported outcomes measure burns
aggressive versus expectant management of severe preeclampsia remote from term

Conditions: Preeclampsia

Summary: how best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. gestational age is the most important determinant of neonatal outcome. there are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. the interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. the purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

severa preeclampsia between 28 and 33 weeks of gestation women and fetus with stable condition all women receive complete dosis of steroids

Eligibility criteria:
inclusion criteria: * pregnancy with severe preeclampsia and 28 to 33 weeks of gestation exclusion criteria: * uncontrollable blood pressure or persistent severe hypertension (160/110 mmhg) * persistent symptoms of preeclampsia * maternal complications (hellp syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema) * fetal death, restriction of fetal grown
a study of detection of paroxysmal events utilizing computer vision and machine learning

Conditions: Epilepsy

Summary: increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. the computer vision and machine learning based solution used in this project (nelli) is an automatic seizure detection and reporting method that has a ce mark for this specific use. the present study will provide data to expand the utility and detection capability of nelli and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

this is a prospective, blind comparison to the clinical gold standard for seizure characterization. this study is intended to compare the nelli software's ability to identify seizure events to veeg review in adults with suspected nighttime seizures. simultaneously, nelli will continuously record audio and video while video-electroencephalography (veeg) is recorded per typical standard of care. events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical veeg data. nelli software will review the audio and video data and independently identify events with positive motor manifestations. the outcomes of event identification will be compared between epileptologists and the nelli software. for each category of event captured the positive percent agreement will be calculated using the exact binomial method. the primary endpoint of this study is to demonstrate that nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility criteria:
inclusion criteria: * all patients undergoing video-eeg monitoring for clinical purposes who are suspected of having seizures. exclusion criteria: -
monitoring the response of chemotherapy on breast cancer tumor by photon migration spectroscopy

Conditions: Breast Cancer

Summary: optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. newly diagnosed breast cancers in the united states with a higher incidence in medically underserved areas. the optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. the goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

the researcher developed a diagnostic device called diffuse optical spectroscopy imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues. diffuse optical spectroscopy imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. the measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. there is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. however, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Eligibility criteria:
inclusion criteria: * female non-pregnant and age greater than or equal to 21 years old but less than 75 years old * diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy exclusion criteria: * female pregnant and age less than 21 years old and have no diagnosis of breast cancer

Keywords: breast cancer receiving chemotherapy
a study evaluating the real world experience of participants treated with briumvi® (ublituximab-xiiy) for relapsing multiple sclerosis (rms)

Conditions: Relapsing Multiple Sclerosis; Multiple Sclerosis

Summary: the purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed briumvi® (ublituximab-xiiy) in the real-world setting


Eligibility criteria:
inclusion criteria: 1. confirmed multiple sclerosis (ms) diagnosis. 2. participants who have not received any briumvi® (ublituximab-xiiy) infusion prior to study start. participants who have been prescribed briumvi® (ublituximab-xiiy) but have not yet received their first infusion on day 1 of 150 milligrams (mg) can be included. exclusion criteria: 1. have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first briumvi® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first briumvi® (ublituximab-xiiy) administration. 2. any active infection (e.g., active hepatitis b virus \[hbv\]) 3. concurrent participation in any interventional ms trials, or planned concurrent treatment with other multiple sclerosis disease modifying therapy (ms dmt) during the study period.
pharmacogenomics of antivegf in patients with age-associated macular degeneration (amd)

Conditions: Wet Age-related Macular Degeneration

Summary: this is a phase iii, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. it will be performed involving 630 eyes from patients with wet age-related macular degeneration (wamd) diagnosis without another eye disease. this clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-vegf used in patients with wamd, (ranibizumab) and the most cost-effective anti-vegf (bevacizumab; off-label use)


Eligibility criteria:
inclusion criteria: * patients diagnosed with neovascular age-related macular degeneration * age of 50 years or older. * that at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-vegf agent as usual in clinical practice. * without previous treatment in the eye under study (no previous treatment for amd). exclusion criteria: * participate or have participated in another clinical trial with an experimental drug in the last 6 months. * patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study. * concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-vegf in the contralateral eye. * high cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months. * ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma. * hypersensitivity to the active substance or to the excipients. * diabetic retinopathy documented. * pregnant or nursing (lactating) women. patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis of genetic polymorphisms and clinical data related to antivegf received out of the clinical trial and av, oct results and adverse events registered in medical records at 6m, 12m, 24m, 36m.

Keywords: wamd antivegf bvz rbz amd pharmacogenomics
eeg detection of delirium

Conditions: Post Operative Delirium

Summary: veegix is a portable device developed by neuroservo for simplifying electroencephalograms at the bedside. it is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. the goal of this study is to determine eeg thresholds for the diagnostic of delirium. methods : this prospective observational study includes patients undergoing orthopedic or degestive surgery. each subject will have an eeg reading before surgery and twice daily after surgery until discharge or up to 5 days. patients will be monitored for post operative delirium using the 3d-confusion assessment method. delirium diagnostic will be confirmed by a geriatrician. eeg relative power reading will be compared between patient with and without a delirium diagnostic.


Eligibility criteria:
inclusion criteria: * 65 years and older * had a orthopedic or digestive surgery * good undersanding of french or english * consent to participate in the study exclusion criteria: * history of seizure or epilepsia * structural brain damage * intelectual deiciency * severe major neurocognitive disorder * incapacity to respond to the questionnaire * hospitalised in intensive care or intubated

Keywords: post operative delirium older adults electroencephalography
a trial to compare raltegravir versus nevirapine as anchor drug for hiv+ chinese idus on methadone maintenance

Conditions: HIV; HIV Infections

Summary: this is a pilot randomized controlled open-label trial to compare raltegravir and nevirapine as anchor drug in combined antiretroviral therapy(art) for art-naive hiv+ chinese injection drug users who are also on methadone maintenance therapy. the investigators hypotheses include: 1. in raltegravir arm compared with nevirapine arm, fewer patients will require methadone dose adjustment to abate methadone withdrawal symptoms. also the average methadone dose to achieve adequate serum methadone concentrations in patients on the raltegravir-based regimen will be lower compared to that of patients on the nevirapine-based regimen. 2. clinical outcomes in terms of viral suppression, cd4 recovery and occurrence of opportunistic infections will be comparable in the two arms at 6 months and one year. 3. patients in the raltegravir arm will have a similar or better side effect profile, retention rate, and treatment adherence compared to those in the nevirapine arm.


Eligibility criteria:
inclusion criteria: * chinese idus with documented hiv-1 infection confirmed by a western blot assay. * on stable methadone maintenance therapy at the time of enrollment. * antiretrovial treatment naïve and meeting clinical criteria of the chinese national guideline to initiate antiretroviral therapy. * patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. acceptable method of birth control is defined as intrauterine device (iud), diaphragm with spermicide, condoms, or abstinence. exclusion criteria: * patients with allergies to or other contraindications for the selected arv regimens. * patients with acute hiv infection. * use of concomitant therapy which can potentially interact with methadone and scheduled arvs. * females who are pregnant, breast-feeding, or planning to get pregnant within the study period and using ineffective or hormonal birth control. (note: all female patients must have a negative pregnancy test at treatment day 1) * any active and clinically significant disease or findings discovered on screening medical history, physical examination and laboratory assessment that are not resolved or stabilized within 30 days before the screening phase of this study. * patients with clinical or laboratory evidence of active liver disease, severe hepatic impairment /dysfunction or cirrhosis or elevated liver enzyme levels. (note: patients co-infected with chronic hepatitis b or c will be allowed to enter the program if their condition is judged to be clinically stable.) * patient's education level that would interfere with the medical, adherence and withdrawal symptoms evaluation.

Keywords: methadone hiv raltegravir antiretroviral intravenous drug user methadone maintenance treatment naive
a study to determine the safety and efficacy of lx3305 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to determine the safety of lx3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * adult subjects, aged 18 to 75 years * active rheumatoid arthritis (ra), class i to iii (defined by the american college of rheumatology), diagnosed at least 3 months prior to screening * minimum of 4 swollen joints (at screening and day 1), minimum of 4 tender joints (at screening and day 1), and serum c-reactive protein (crp) level \>1.2x the upper limit of normal and/or elevated erythrocyte sedimentation rate (esr) * if receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated for at least 6 weeks prior to screening and currently receiving a stable dose of methotrexate (mtx) with a stable route of administration, and have no plans to change mtx dose during the study * ability to give written informed consent exclusion criteria: * women who are pregnant or nursing * ra diagnosis prior to 16 years of age (juvenile ra) * intra-articular and/or parenteral corticosteroids within 4 weeks of study day 1 * receipt of live vaccine within 4 weeks prior to day 1 * major surgical procedure within 8 weeks prior to day 1 * blood donation within 4 weeks prior to day 1 * any systemic inflammatory condition * history of bleeding diathesis * history of medically significant opportunistic infection * history of drug or alcohol abuse within 3 years prior to day 1 * history of cancer within 5 years prior to day 1 * presence of hepatic or biliary disease * history of tuberculosis * history of human immunodeficiency virus (hiv) * any clinically significant laboratory test results, in the opinion of the investigator * use of any investigational agent or participation in an investigative trial within 30 days of day 1 * concurrent use of any biologic agent for the treatment of ra or concomitant disease modifying antirheumatoid drugs (other than mtx, hydroxychloroquine, leflunomide, and sulfasalazine - at stables doses for 8 weeks)
comparison of radiofrequency, vein stripping and chiva for venous insufficency

Conditions: Varicose Veins

Summary: randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (chiva) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

a randomized controlled trial will compare three surgical techniques (stripping, chiva and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care. the trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by doppler with diameter greater than 4 mm. clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. the primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. secondary variables will include vas for pain and quality of life as assessed by the sf 36 and civiq questionnaires validated in spanish language. ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. intra- and postoperative complications will be recorded.

Eligibility criteria:
inclusion criteria: * insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by eco- dupplex. * age \> 18 years * informed consent exclusion criteria: * recurrent varicose veins * post-thrombotic syndrome. * patients with active malignancies or severe ischemic heart disease. * serious liver disease * thrombophilia. * serious psychiatric diseases

Keywords: varicose veins